Early Detection of Breast Cancer Using Tomosynthesis Imaging
The purpose is to develop digital tomosynthesis to improve the detection of breast cancers. The aims are optimizing digital mammography and tomosynthesis acquisition, creating visualization tools, prospective pilot studies to evaluate radiologist performance, and computer-aided detection.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Early Detection of Breast Cancer Using Tomosynthesis Imaging|
- Radiologist ROC (receiver operating characteristic) area under curve (AUC) [ Time Frame: at imaging review by the end of the study, approximately 9 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2004|
|Study Completion Date:||October 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Tomosynthesis scans
This is a case-only study with only one group/cohort. All women receive both mammography and tomosynthesis imaging.
Radiation: Mammography and tomosynthesis imaging
All subjects receive the same radiation dose associated with mammography and tomosynthesis imaging (which is comparable to mammography).
Finding breast cancer early has been shown to improve the chance of survival. Mammography (x-ray imaging of the breast) helps find breast cancer early. Some breast cancers, however, are not seen on mammography, which creates two-dimensional images for the radiologist to see. The goal of this study is to make a breast tomosynthesis or tomosynthesis 3D (three-dimensional) x-ray system by taking x-ray images from many angles. This is similar to a CAT (computerized axial tomography) scan for the breast and can give radiologists 3D information so that they can find breast cancers which might otherwise be hidden from view.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637598
|United States, North Carolina|
|DUMC Mammography, Duke South Hospital, 2nd floor|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Joseph Y Lo, PhD||Duke University Health System|